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CTRI Number  CTRI/2024/10/076096 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The Effect Of Jatamamsi Taila Padabhyanga In The Management Of Insomnia Disorder 
Scientific Title of Study   A Randomized Controlled Clinical Trial To Evaluate The Effect Of Jatamamsi Taila Padabhyanga In The Management Of Insomnia Disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meghana M Dave  
Designation  P.G. SCHOLAR 
Affiliation  G.J. Patel Institue Of Ayurvedic Studies & Research  
Address  Department Of Kayachikitsa , OPD number -14, S.G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat- 388121, India

Anand
GUJARAT
388121
India 
Phone  8200763070  
Fax    
Email  meghadave113@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSoumya EA  
Designation  Associate Professor  
Affiliation  G.J. Patel Institue Of Ayurvedic Studies & Research  
Address  Department Of Kayachikitsa , OPD number -14, S.G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat - 388121, India

Anand
GUJARAT
388121
India 
Phone  9847003989  
Fax    
Email  soumya.ea@cvmu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Meghana M Dave  
Designation  P.G. SCHOLAR 
Affiliation  G.J. Patel Institue Of Ayurvedic Studies & Research  
Address  Department Of Kayachikitsa , OPD number -14, S.G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat- 388121, India

Anand
GUJARAT
388121
India 
Phone  8200763070  
Fax    
Email  meghadave113@gmail.com  
 
Source of Monetary or Material Support  
S.G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat,India -388121 
 
Primary Sponsor  
Name  Dr. Meghana M. Dave 
Address  Department Of Kayachikitsa , OPD number -14, S.G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar -388121 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NILL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meghana M Dave  S. G. Patel Ayurveda Hospital and Maternity Home  Department Of Kayachikitsa , OPD number -14, S.G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat- 388121, India
Anand
GUJARAT 		 8200763070

meghadave113@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
G.J Patel Institute Of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics  Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Su.Ch.24/30, Procedure details: Fill 10 ml lukewarm oil(for each foot sole) into the Applicator & apply oil in stroking pattern from heel to toe & toe to heel at feet sole (padatala) 5 min for each sole )
(1) Medicine Name: jatamamsi, Reference: प्रियनिघण्टु, शतपुष्पादिवर्ग,३६), Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Duration: 1 Months
(2) Medicine Name: tila taila, Reference: Bhav .prakash poorvakhanda , taila varga 2-11, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Duration: 1 Months
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  .Participants fulfilling the diagnostic criteria as per DSM-v
.Individuals between the age group of 30 to 60 years irrespective of gender.
.Those who are willing to give consent letter. 
 
ExclusionCriteria 
Details  .Participent suffering from systemic disorders like renal failure, heart disease, Psychiatric disorders & others chronic disorders.
.Insomnia due to any other health condition
.Pregnant women and lactating mothers.
.Participent with alcohol dependency or Medication dependency.
.Participent who are already on treatment for insomnia.
.Participent suffering from chronic insomnia that was addicted to sedative medication and taking any drugs possessing sedative effect will be excluded.



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvment in quality of slepp in terms of depth of sleep   Assessment will be done on 8th day ,15th day & 30 th day  
 
Secondary Outcome  
Outcome  TimePoints 
To develop sop for planter oil applicator   30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A  Randomized control clinical study  is planned to assess the effectiveness of jatamamsi taila padabhyanga in the management of insomnia disorder. In this study, 30 persons are participants divided into 2 groups between the age group of 30 to 60 years who fulfil the criteria taken for the study. They will be selected by a randomly (computerized) allocated  into 2 groups,  Groups A and B. Persons will be assessed as per symptoms and their assessment tools. The duration of the study will be 1 month and the Follow-up period is on 0th day, 8th day, 15th day and 30th day.
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